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Dynamic EU MDR 2017/745 Full Text
Chapter 1 (Art 1 - 4) Scope and definitions
Chapter 2 (Art 5 - 24) – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
Chapter 4 (Art 35 - 50) – Notified bodies
Chapter 5 (Art. 51 – 60) Classification and conformity assessment
Chapter 6 (Art. 61 – 82) Clinical evaluation and clinical investigations
Chapter 7 (Art. 83 – 100) Post-market surveillance, vigilance and market surveillance
Chapter 8 (Art. 101 – 108) Cooperation between member states, medical device coordination group, expert laboratories, expert panels and device registers
Chapter 9 (Art. 109 – 113) Confidentiality, data protection, funding and penalties
Chapter 10 (Art. 114 – 123) Final provisions
Annexes
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Chapter 3 (Art 25 - 34) – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices

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Article 31 – Registration of manufacturers, authorised representatives and importers

Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in
Article 30
⁠
the information referred to in Section 1 of Part A of
Annex VI
⁠
, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to
Article 52
⁠
, the information referred to in Section 1 of Part A of
Annex VI
⁠
shall be provided to that electronic system before applying to the notified body.
After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in
Article 30
⁠
and issue it to the manufacturer, the authorised representative or the importer.
The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under
Article 29
⁠
.
Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in
Article 30
⁠
.
Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.
Without prejudice to the economic operator’s responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of
Annex VI
⁠
.
The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in
Article 30
⁠
shall be accessible to the public.
The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to
Article 111
⁠
.
⁠
🎁
MDCG 2021-13 Rev. 1
⁠
presents a Q&A on obligations and rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers
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